{"id":3081,"date":"2019-04-24T08:21:10","date_gmt":"2019-04-24T06:21:10","guid":{"rendered":"https:\/\/alzheimer.noemi.lu\/?p=3081"},"modified":"2019-04-24T08:21:10","modified_gmt":"2019-04-24T06:21:10","slug":"interview-with-scott-berry","status":"publish","type":"post","link":"https:\/\/ep-ad.org\/index.php\/2019\/04\/24\/interview-with-scott-berry\/","title":{"rendered":"Interview with Scott Berry"},"content":{"rendered":"\n<p><strong>What is your current role in EPAD?<\/strong><\/p>\n\n\n\n<p>I am a co-lead of Work Package 2 \u2013 The Statistical Engine Room.\u00a0 The Statistical Work Package has two main focuses in the EPAD project \u2013 the design of the proof-of-concept platform trial and the disease modeling work from the Longitudinal Cohort Study (LCS).\u00a0 I have been focused on working with the EPAD team to create a platform trial design for the phase 2 proof-of-concept trial (PoC). This will allow multiple therapies to be investigated simultaneously in the same protocol creating a great deal of synergy \u2013 for example sharing controls across arms. <\/p>\n\n\n\n<p><strong>What did you do prior to joining EPAD?<\/strong><\/p>\n\n\n\n<p>I\nam a PhD Statistician and President at Berry Consultants, a statistical\nconsulting company specializing in designing adaptive and innovative trial\ndesigns, typically from a Bayesian perspective.&nbsp;\nWe work for a wide range of sponsors \u2013 large and small pharma, device\ncompanies, federally funded trials, and NGO based efforts.&nbsp; We work on designing flexible adaptive\ntrials.&nbsp; This process involves creating\nthe modeling and adaptive features of a design.&nbsp;\nTypically, this involves detailed clinical trial simulations in order to\noptimize the design \u2013 making sure that the adaptive features, modeling and\nthreshold are all optimized for the goals of the trial.&nbsp; The design of adaptive trials is a very\ndetailed process of iterative trial design aspects tied to detailed clinical\ntrial simulations.&nbsp; Traditional, fixed,\ntrials can be understood with pencil-and-paper calculations, but more complex trial\ndesigns are simulated to understand their behavior \u2013 much like the simulation\ndesign of airplanes, automobiles, and bridges \u2013 well almost everything\nnowadays.&nbsp; Trials constructed through\nsimulations have been given the moniker of \u201ccomplex\u201d innovative trials.&nbsp; This has been the space of trial designs we\nhave been working on.&nbsp; <\/p>\n\n\n\n<p>Recently\nplatform trials have been gaining in popularity.&nbsp; The I-Spy2 trial was one of the first\nplatform trails (with more than 14 different experimental agents moving through\nthe phase 2 trial) and its popularity and growing need for more efficient\nmethods have led to this growth and demand for platform trials. &nbsp;Platform trials are being constructed in\nmultiple cancers, ALS, Duchenne muscular dystrophy, various infectious\ndiseases, PTSD, as well as familial Alzheimer\u2019s.&nbsp; These trials typically fall in this bucket of\ncomplex trial designs.&nbsp; &nbsp;<\/p>\n\n\n\n<p><strong>Tell us a bit about the institution\/company\/organisation you work for.<\/strong><\/p>\n\n\n\n<p>Berry\nConsultants has offices in the UK and the United States, and we focus on\nstatistical innovation \u2013 typically tied to the design and analysis of\ninnovative trial designs.&nbsp; Berry\nConsultants is approaching its 20<sup>th<\/sup> year \u2013 after being founded in\n2000 by Don Berry and myself.&nbsp; We have\nsince grown to more than 30 employees \u2013 experts in statistics, clinical trials,\nand clinical trial simulation.&nbsp; In\naddition to the design of trials, Berry Consultants has created and continues\nto develop a software package for clinical trial simulations, for the\nevaluation and optimization of trial designs (Fixed and Adaptive Clinical Trial\nSimulator, FACTS).&nbsp; <\/p>\n\n\n\n<p><strong>What are your expectations from the EPAD project?<\/strong><\/p>\n\n\n\n<p>I have incredibly high hopes for EPAD.&nbsp; I believe the PoC trial that comes out of the EPAD project will continue perpetually as long as there is a need in the slowing and prevention of Alzheimer\u2019s disease.&nbsp; The project is unique in the construction of the LCS feeding to the PoC trial.&nbsp; I believe the PoC trial will prove to be an incredibly efficient \u2018machine\u2019 for phase 2 Alzheimer\u2019s drugs \u2013 which will decrease costs, improve timelines, and ultimately improve the industries ability to investigate experimental drugs.&nbsp; Not only will this have substantial impact on Alzheimer\u2019s disease but the project itself will likely become a model project that can be emulated in many other diseases.&nbsp;  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>What is your current role in EPAD? I am a co-lead of Work Package 2 \u2013 The Statistical Engine Room.\u00a0 The Statistical Work Package has two main focuses in the EPAD project \u2013 the design of the proof-of-concept platform trial and the disease modeling work from the Longitudinal Cohort Study (LCS).\u00a0 I have been focused [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3106,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-3081","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts\/3081","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/comments?post=3081"}],"version-history":[{"count":0,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts\/3081\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/media\/3106"}],"wp:attachment":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/media?parent=3081"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/categories?post=3081"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/tags?post=3081"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}